The goal of this Phase I project is to develop a cell-coated device for the treatment of acute liver failure. The device harnesses mesenchymal stem cell secretions to provide combined anti-inflammatory and regenerative support. The project specific aims are: (1) Positron emission tomography (PET)-guided optimization of cellular coatings; and (2) To perform a dose escalation therapeutic trial in an acetaminophen-induced liver failure model in dogs. The deliverable of this completed project will be therapeutic proof-of concept data that can be optimized in large animals during Phase II funding. PUBLIC HEALTH RELEVANCE: Biotechnologies Inc. has developed an extracorporeal device that has the potential to offer unparalleled support to patients undergoing acute liver failure. Th Sentien device delivers to the patient a broad-spectrum array of secreted factors from mesenchymal stem cells. Collectively, these factors protect the injured organ from inflammation and promote endogenous repair programs. This combinatorial approach to liver therapy is distinguishable from the competition and promises to become a disruptive technology. Sentien now seeks funding to finalize its pre-clinical development by creating optimized cellular coatings and performing subsequent in vivo testing in large animal models of liver failure. At the end of these studies, Sentien expects to have sufficient evidence of pre-clinical efficacy to motivate initial trials of this device in humans.